Patient is 18 years old; or is an emancipated minor as defined by Ugandan law or is under 18 but has a parent/guardian who provides informed consent.

Patient agrees to follow-up schedule.

Patient presents with a leaking vesico-vaginal fistula, confirmed by exam, with no signs of acute inflammation, no signs of active urinary tract infection that cannot be controlled with a standard pre-operative course of antibiotics, no signs of vaginal infection, or no signs of abscess.

Patient presents with a fistula of a size and in a location that may be reasonably treated with the VVP device.

Exclusion Criteria:

Patient is not medically fit enough for surgery under general or spinal anesthesia.

Patient is a "mature minor" as defined by Ugandan law.

Patient is pregnant, breastfeeding or planning further pregnancy during the study period.

Patient has physical allergies or cultural objections to the receipt of porcine products.

Patient has an active sexually transmitted disease, is HIV-positive, or any other active systemic infection that may interfere with healing.

Patient has spina bifida or other neural tube defect.

Patient has interstitial cystitis or other chronic pelvic pain syndrome.

Patient has signs of acute or chronic pelvic inflammation, active urinary tract infection not responsive to antibiotic treatment, vaginal infection, or abscess of the fistula tract.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923338